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Civigel 0.2% Liquid Eye Gel

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1. What Viscotears® Liquid Gel is and what it’s used foi


2. Things to consider before you start to use Viscotears® Liquid Gel


3. How to use Viscotears® Liquid Gel


Viscotears® Liquid Gel / Civigel® 0.2% Liquid Eye Gel

(Carbomer 980)

Patient Information Leaflet

This product will be called Viscotears® Liquid Gel in this leaflet.

Please read this leaflet carefully before you start to use

Viscotears® Liquid Gel. It contains important information.

-    Keep the leaflet in a safe place because you may want to read it again.

-    Do not share these eye drops with anyone else just in case you have an eye infection, which you could pass on.

-    If you have any other questions, or if there is something you don't understand, please ask your pharmacist.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Viscotears® Liquid Gel is and what it's used for

2.    Things to consider before you start to use Viscotears® Liquid Gel

3.    How Viscotears® Liquid Gel is used

4.    Possible side effects

5.    How to store Viscotears® Liquid Gel

6.    Further information

Viscotears® Liquid Gel contains the active ingredient, carbomer (polyacrylic acid). Viscotears® Liquid Gel is used to make your eyes more comfortable when they feel dry. It is one of a group of eye drops called 'artificial tears'.

DO NOT use Viscotears® Liquid Gel if:

•    you think you may be allergic to any of the ingredients. (These are listed at the end of the leaflet.)

Take special care:

•    In children and adolescents aged to 18 years, the safety and efficacy of Viscotears® Liquid Gel at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.

You should also ask yourself these questions before starting

to use Viscotears® Liquid Gel:

•    Do you wear contact lenses? Take your lenses out before you put the drops in your eyes. Don't put the lenses back in for at least 30 minutes.

•    Do you have problems with your eyes apart from sore or dry eyes? Talk to your doctor before you start to use Viscotears® Liquid Gel.

•    Are you using any other eye drops?

If you need to use more than one kind of eye drops wait 5 minutes between treatments. Viscotears® Liquid Gel should always be the last of the eye drops used.

•    Are you pregnant or breast-feeding? Discuss whether you should use Viscotears® Liquid Gel with your doctor.

Will there be any problems with driving or using machinery?

Some people may find that their vision is blurred immediately after

using Viscotears® Liquid Gel. If affected, wait until your vision

clears before you drive or use machinery.

If your doctor has prescribed Viscotears® Liquid Gel he/she will tell you how and when to use it and the dose will be on the pharmacist's label.

The usual dosage is:

Adults (including the elderly): One drop in each affected eye, three or four times a day.

Children and adolescents aged to 18 years:

The safety and efficacy of Viscotears® Liquid Gel in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.

If you are not sure ask your doctor or pharmacist.

How to use your eye drops

1.    Wash your hands.

2.    If you wear contact lenses, remove them before using the drops and do not replace for at least 30 minutes.

3.    Hold the tube vertically (see figure 1).

4.    Tilt your head backwards (see figure 2).

5.    Rest one hand on your cheek and gently pull down your lower eye lid.

6.    Look upwards.

7.    Insert one drop by squeezing the tube gently (see figure 3).

8.    Blink a few times to spread the liquid gel evenly over your eye.

9.    Wipe away any excess gel from around the eyelids.

10.    Repeat for your other eye if required.

NOTE: Do not touch your eye or the surrounding area with the tip of the dropper as this may cause injury to the eye and contaminate the gel. Follow the instructions carefully. If there is anything you don't understand, ask your pharmacist or doctor.

Do not use Viscotears® Liquid Gel later than four weeks after first opening.


4. Possible side effects

Viscotears® Liquid Gel is suitable for most people, but, like all medicines, it can sometimes cause side effects.

Sometimes people notice that the drops make their eyes burn or sting slightly. This usually quickly passes.

Viscotears® Liquid Gel can make your eyelids feel sticky.

Sometimes your vision may be blurred for a short time. This will gradually clear (but do not drive or operate machinery while affected).

There have been reports of allergic reactions, eyelid swelling, eye redness, swelling, pain and itching following the use of Viscotears® Liquid Gel.

These effects are often mild. If they are severe, or if you notice anything else not mentioned here, please go and see your doctor.

5. How to store Viscotears® Liquid Gel


•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Discard 28 days after first opening.

•    Do not use the eye drops after the expiry date shown on the tube (EXP).

•    If your doctor tells you to stop taking the medicine, please take them back to the pharmacist for safe disposal. Do not throw it away with your normal household water or waste. This will help to protect the environment.

•    If the medicine become discoloured or show signs of any deterioration, you should seek the advise of your pharmacist.

What Viscotears® Liquid Gel contains

®

The name of your eye drops is Viscotears Liquid Gel. Each gram of eye gel contains 2mg of the active ingredient carbomer 980.

Your medicine also contains: Cetrimide, Sorbitol, Sodium Hydroxide and Water for injection.

What Viscotears® Liquid Gel looks like and the contents of the pack

®

Viscotears Liquid Gel comes as a clear, colourless, odourless gel in a plastic tube. The pack contains one tube with a nozzle applicator containing 10g of sterile colourless and odourless liquid eye gel.

Manufacturer

This product is manufactured by Novartis Pharma SAS, 26 Rue de la Chapelle, 68330 Huningue, France and procured from within the EU by the Product Licence holder Delta Pharma (Europe) Ltd, 1 Colonial Way, P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by O.P.D. Laboratories Ltd, Watford, Herts WD24 4PR.

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PL No: 17805/0202

Leaflet revision date: 13/03/2013

Viscotears is a registered Trade Mark of Novartis AG, Switzerland. To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.